11/07/2025 updated
ZW
100 % available
Senior Regulatory Affairs Associate - Clinical Trial Submissions & Study Start-Up
Aarhus, Denmark
Only remote
MSc in Medicine with Industrial SpecialisationBusiness EfficiencyBusiness Process ImprovementClinical ResearchClinical Trial Management SystemsComplianceDatabasesDocument Management SystemsDocument ProductionElectronic Common Technical DocumentQuality ManagementLifecycle ManagementRegulatory Affairs
Clinical Trial Submissions
Expertise in EU CTR via CTIS submissions and national procedures across multiple countries including Denmark, Nordics, UK, and Switzerland
Regulatory Affairs Management
Comprehensive lifecycle management of regulatory submissions including CTA amendments, site activation, and cross-functional collaboration
Study Start-Up Operations
Site feasibility assessments, activation processes, and regulatory document preparation from feasibility to site initiation visits
Document Management Systems
Proficiency in CTIS, Veeva Vault, eCTD/CTD, RIMS, CESP, CTMS, and regulatory databases for document tracking and compliance
Regulatory Compliance
TMF and ISF management, GCP compliance, inspection readiness, and regulatory framework knowledge including EMA, FDA, MDR, and GCP
Cross-Functional Collaboration
Coordination with CRAs, CMCs, QA, Legal teams, Site Coordinators, and regulatory authorities across multiple therapeutic areas
Process Improvement
Development of SOPs, work instructions, checklists, templates, and country-specific regulatory procedures for operational efficiency
Translation and Localization
Country-specific document customization, ICF preparation, patient materials translation, and Danish regulatory document review
Expertise in EU CTR via CTIS submissions and national procedures across multiple countries including Denmark, Nordics, UK, and Switzerland
Regulatory Affairs Management
Comprehensive lifecycle management of regulatory submissions including CTA amendments, site activation, and cross-functional collaboration
Study Start-Up Operations
Site feasibility assessments, activation processes, and regulatory document preparation from feasibility to site initiation visits
Document Management Systems
Proficiency in CTIS, Veeva Vault, eCTD/CTD, RIMS, CESP, CTMS, and regulatory databases for document tracking and compliance
Regulatory Compliance
TMF and ISF management, GCP compliance, inspection readiness, and regulatory framework knowledge including EMA, FDA, MDR, and GCP
Cross-Functional Collaboration
Coordination with CRAs, CMCs, QA, Legal teams, Site Coordinators, and regulatory authorities across multiple therapeutic areas
Process Improvement
Development of SOPs, work instructions, checklists, templates, and country-specific regulatory procedures for operational efficiency
Translation and Localization
Country-specific document customization, ICF preparation, patient materials translation, and Danish regulatory document review
Experience
Professional experience5 - 10 years
Freelancer since2025
Languages
DanishFluentEnglishFluent
Project history
Managing clinical trial submissions under EU CTR via CTIS across Denmark, Nordics, other EU countries, UK, and Switzerland. Compiling, reviewing, and submitting country-specific documentation for initial CTA, amendments, and site activation.
Led CTA submissions and lifecycle amendments under EU CTR and national procedures across Nordic countries. Managed site activation, submission readiness, TMF compliance, and conducted Site Initiation Visits while mentoring site staff on compliance and study procedures.
Managed end-to-end study start-up and regulatory submissions across multiple sponsors and therapeutic areas. Acted as main point of contact for Ethics Committees and Health Authorities, prepared submission packages, and customized country-specific documents including ICFs.